Sodium Management in Acute and Chronic Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2000-09-30

Study Completion Date

2010-03-31

Brief Summary

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The study was aimed to verify the effects of Hypertonic saline solution (HSS) and a moderate sodium (Na) restriction plus high furosemide dose in the short term (hospitalization time) and a moderate Na restriction in the long term on readmissions and mortality in patients in III NYHA class.

Detailed Description

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Conditions

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Heart Failure

Keywords

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Heart failure III NYHA class Furosemide Sodium water restriction decompensated heart failure Hypertonic saline solution Moderate sodium restriction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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low sodium diet 80 mmol/day

No interventions assigned to this group

moderate sodium intake 120 mmol/day

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Decompensated HF due to ischemic or nonischemic cardiomyopathy,
* \>18 years of age,
* HF according to Framingham criteria
* NYHA functional class III
* EF \<40%,
* Serum creatinine \<2,5 mg/dL
* BUN \<60 mg/dL,

Exclusion Criteria

* NYHA class \> III or \< III,
* Cerebral vascular disease,
* Dementia,
* Cancer,
* Uncompensated diabetes,
* Severe hepatic disease
* Patients requiring pacemaker
* Previous RCT implantation
* Alcoholic habit

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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GF Ingrassia Hospital

Palermo, , Italy

Site Status

Countries

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Italy

Other Identifiers

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G.F. Ingrassia Hospital,Italy

Identifier Type: -

Identifier Source: org_study_id